Circulatory support pump centering anchoring and centering device

ABSTRACT

Embodiments in the present disclosure relate to an anchoring and centering device for a circulatory support pump. An exemplary apparatus comprises an expandable anchoring device extending along a longitudinal axis, wherein the expandable anchoring device is arranged about a central axis. A distal portion of the expandable anchoring device defines an annulus through which the cardiac pump can be arranged and to which the cardiac pump can be releasable coupled. A proximal portion of the expandable anchoring device is configured to circumferentially expand to an unconstrained configuration that has a cross-sectional diameter greater than a diameter of the annulus. The exemplary apparatus also includes a constraining member arranged over the expandable anchoring device to constrain the expandable anchoring device in a constrained configuration for delivery of the anchoring apparatus.

CROSS REFERENCE TO RELATED APPLICATION

This application claims priority to Provisional Application No.62/889,674, filed Aug. 21, 2019, which is herein incorporated byreference in its entirety.

TECHNICAL FIELD

The present disclosure relates to percutaneous circulatory supportdevices. More specifically, the disclosure relates to an anchoring andcentering device for a circulatory support pump.

BACKGROUND

Circulatory support devices are devices that support the pumping actionof the heart. These devices may be disposed through a valve opening suchas, for example, an aortic valve. Typical circulatory support devicesare prone to moving, resulting in a need for repositioning beforetreatment is continued.

SUMMARY

Embodiments disclosed herein relate to anchoring and centering devicesfor a circulatory support pump. Exemplary embodiments include, but arenot limited, to the following examples.

In an Example 1, an anchoring apparatus for centering a cardiac pump,comprises: an expandable anchoring device extending along a longitudinalaxis, wherein the expandable anchoring device is arranged about acentral axis, wherein a distal portion of the expandable anchoringdevice defines an annulus through which the cardiac pump can be arrangedand to which the cardiac pump can be releasable coupled, and wherein aproximal portion of the expandable anchoring device is configured tocircumferentially expand to an unconstrained configuration that has across-sectional diameter greater than a diameter of the annulus; and aconstraining member arranged over the expandable anchoring device toconstrain the expandable anchoring device in a constrained configurationfor delivery of the anchoring apparatus.

In an Example 2, the apparatus of Example 1, wherein the proximalportion has a conical shape.

In an Example 3, the apparatus of any one of Examples 1 or 2, whereinthe proximal portion comprises a plurality of proximal portions that areconfigured to expand equidistant from the central axis when in theunconstrained configuration.

In an Example 4, the apparatus of Example 3, wherein the plurality ofproximal portions comprise a plurality of separate, elongate members.

In an Example 5, the apparatus of Example 4, wherein the plurality ofseparate, elongate members are barbs.

In an Example 6, the apparatus of any one of Examples 3-5, wherein theplurality of proximal portions comprises a plurality of loop elements.

In an Example 7, the apparatus of any one of Examples 1-6, wherein thedistal portion includes an elongate member that is secured to a couplingloop of the cardiac pump via an interference fit.

In an Example 8, the apparatus of any one of Examples 1-7, wherein thedistal portion comprises portions that are overlapping when in theconstrained configuration and are non-overlapping when in theunconstrained configuration.

In an Example 9, the apparatus of any one of Examples 1-8, furthercomprising a delivery catheter, wherein the delivery catheter has atricuspid cross-sectional shape, and wherein the anchoring apparatus isarranged over the delivery catheter during delivery of the anchoringapparatus.

In an Example 10, the apparatus of any one of Examples 1-9, wherein theplurality of expandable anchoring devices are formed from nitinol.

In an Example 11, a method for delivering an anchoring apparatus forcentering a cardiac pump, the method comprising: arranging the anchoringapparatus over or within a delivery catheter, the anchoring apparatuscomprising: an expandable anchoring device extending along alongitudinal axis, wherein the expandable anchoring device is arrangedabout a central axis, wherein a distal portion of the expandableanchoring device defines an annulus through which the cardiac pump canbe arranged and to which the cardiac pump can be releasable coupled, andwherein a proximal portion of the expandable anchoring device isconfigured to circumferentially expand to an unconstrained configurationthat has a cross-sectional diameter greater than a diameter of theannulus; and a constraining member arranged over the expandableanchoring device to constrain the expandable anchoring device in aconstrained configuration for delivery of the anchoring apparatus;advancing the apparatus over the cardiac pump arranged within asubject's heart; releasably coupling the anchoring apparatus to thecardiac pump; and actuating the anchoring apparatus from its constrainedconfiguration.

In an Example 12, the method of Example 11, wherein the anchoringapparatus further comprises an actuation member, wherein theconstraining member is a sheath arranged around the proximal portionthat comprises at least one aperture, and wherein actuating theanchoring apparatus comprises actuating the actuation member so theanchoring apparatus projects through the at least one aperture of thesheath.

In an Example 13, the method of Example 11, wherein the constrainingmember is a sheath arranged around the proximal portion, and whereinactuating the anchoring apparatus comprises translating the sheath sothat it is no longer arranged around the proximal portion.

In an Example 14, the method of any one of Examples 11-13, wherein thedistal portion includes an elongate member that is secured to a couplingloop of the cardiac pump via an interference fit, and wherein releasablycoupling the anchoring apparatus to the cardiac pump comprises insertingthe elongate member through the coupling loop.

In an Example 15, the method of any one of Examples 11-14, furthercomprising removing the anchoring apparatus by arranging theconstraining member over the expandable anchoring device and withdrawingthe anchoring apparatus.

In an Example 16, an anchoring apparatus for centering a cardiac pump,comprises: an expandable anchoring device extending along a longitudinalaxis, wherein the expandable anchoring device is arranged about acentral axis, wherein a distal portion of the expandable anchoringdevice defines an annulus through which the cardiac pump can be arrangedand to which the cardiac pump can be releasable coupled, and wherein aproximal portion of the expandable anchoring device is configured tocircumferentially expand to an unconstrained configuration that has across-sectional diameter greater than a diameter of the annulus; and aconstraining member arranged over the expandable anchoring device toconstrain the expandable anchoring device in a constrained configurationfor delivery of the anchoring apparatus.

In an Example 17, the apparatus of Example 16, wherein the proximalportion has a conical shape.

In an Example 18, the apparatus of Example 16, wherein thecross-sectional shape of the proximal portion is a disk.

In an Example 19, the apparatus of Example 16, wherein the proximalportion comprises a plurality of proximal portions that are configuredto expand equidistant from the central axis when in the unconstrainedconfiguration.

In an Example 20, the apparatus of Example 19, wherein the plurality ofproximal portions comprise a plurality of separate, elongate members.

In an Example 21, the apparatus of Example 20, wherein the plurality ofseparate, elongate members are barbs.

In an Example 22, the apparatus of Example 19, wherein the plurality ofproximal portions comprises a plurality of loop elements.

In an Example 23, the apparatus of Example 16, wherein the distalportion includes an elongate member that is secured to a coupling loopof the cardiac pump via an interference fit

In an Example 24, the apparatus of Example 16, wherein the distalportion comprises overlapping portions when in the constrainedconfiguration and are non-overlapping when in the unconstrainedconfiguration.

In an Example 25, the apparatus of Example 16, further comprising adelivery catheter, wherein the delivery catheter has a tricuspidcross-sectional shape, and wherein the anchoring apparatus is arrangedover the delivery catheter during delivery of the anchoring apparatus.

In an Example 26, the apparatus of Example 16, wherein the plurality ofexpandable anchoring devices are formed from nitinol.

In an Example 27, a method for delivering an anchoring apparatus forcentering a cardiac pump, the method comprises: arranging the anchoringapparatus over or within a delivery catheter, the anchoring apparatuscomprising: an expandable anchoring device extending along alongitudinal axis, wherein the expandable anchoring device is arrangedabout a central axis, wherein a distal portion of the expandableanchoring device defines an annulus through which the cardiac pump canbe arranged and to which the cardiac pump can be releasable coupled, andwherein a proximal portion of the expandable anchoring device isconfigured to circumferentially expand to an unconstrained configurationthat has a cross-sectional diameter greater than a diameter of theannulus; and a constraining member arranged over the expandableanchoring device to constrain the expandable anchoring device in aconstrained configuration for delivery of the anchoring apparatus;advancing the apparatus over the cardiac pump arranged within asubject's heart; releasably coupling the anchoring apparatus to thecardiac pump; and actuating the anchoring apparatus from its constrainedconfiguration.

In an Example 28, the method of Example 27, wherein the anchoringapparatus further comprises an actuation member, wherein theconstraining member is a sheath arranged around the proximal portionthat comprises at least one aperture, and wherein actuating theanchoring apparatus comprises actuating the actuation member so theanchoring apparatus projects through the at least one aperture of thesheath.

In an Example 29, the method of Example 27, wherein the constrainingmember is a sheath arranged around the proximal portion, and whereinactuating the anchoring apparatus comprises translating the sheath sothat it is no longer arranged around the proximal portion.

In an Example 30, the method of Example 27, wherein the distal portionincludes an elongate member that is secured to a coupling loop of thecardiac pump via an interference fit, and wherein releasably couplingthe anchoring apparatus to the cardiac pump comprises inserting theelongate member through the coupling loop.

In an Example 31, the method of Example 27, further comprising removingthe anchoring apparatus by arranging the constraining member over theexpandable anchoring device and withdrawing the anchoring apparatus.

In an Example 32, the method of Example 27, wherein the proximal portionhas a conical shape.

In an Example 33, the method of Example 27, wherein the distal portioncomprises portions that are overlapping when in the constrainedconfiguration and are non-overlapping when in the unconstrainedconfiguration.

In an Example 34, the method of Example 27, wherein the proximal portioncomprises a plurality of proximal portions that are configured to expandequidistant from the central axis when in the unconstrainedconfiguration.

In an Example 35, the method of Example 33, wherein the plurality ofproximal portions comprise a plurality of separate, elongate members.

While multiple embodiments are disclosed, still other embodiments of thepresently disclosed subject matter will become apparent to those skilledin the art from the following detailed description, which shows anddescribes illustrative embodiments of the disclosed subject matter.Accordingly, the drawings and detailed description are to be regarded asillustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a conceptual diagram of a circulatory support devicehaving an exemplary anchoring device anchored within a heart, inaccordance with embodiments of the subject matter disclosed herein.

FIG. 2 depicts a conceptual diagram of an exemplary implantationlocation of a circulatory support device having an exemplary anchoringdevice, in accordance with embodiments of the subject matter disclosedherein.

FIG. 3 depicts a side view of a circulatory support device having anexemplary anchoring device, in accordance with embodiments of thesubject matter disclosed herein.

FIG. 4A depicts a side view of a portion of a circulatory support devicehaving another exemplary anchoring device, in accordance withembodiments of the subject matter disclosed herein.

FIG. 4B depicts an end view of the circulatory support device of FIG.4A, in accordance with embodiments of the subject matter disclosedherein.

FIGS. 5A and 5B depict a conceptual end view of another exemplaryanchoring device, in accordance with embodiments of the subject matterdisclosed herein.

FIG. 6 depicts a conceptual cross-sectional delivery catheter, inaccordance with embodiments of the subject matter disclosed herein.

FIGS. 7A and 7B are schematic diagrams depicting operation of anexemplary anchoring deployment mechanism, in accordance with embodimentsof the subject matter disclosed herein.

FIGS. 8A and 8B are schematic diagrams depicting operation of anotherexemplary anchoring deployment mechanism, in accordance with embodimentsof the subject matter disclosed herein.

FIGS. 9A and 9B are schematic diagrams depicting operation of anotherexemplary anchoring deployment mechanism, in accordance with embodimentsof the subject matter disclosed herein.

FIGS. 10A and 10B are schematic diagrams depicting operation of anotherexemplary anchoring deployment mechanism, in accordance with embodimentsof the subject matter disclosed herein.

FIGS. 11A and 11B are schematic diagrams depicting operation of anotherexemplary anchoring deployment mechanism, in accordance with embodimentsof the subject matter disclosed herein.

FIGS. 12A-12C are schematic diagrams depicting operation of anotherexemplary anchoring deployment mechanism, in accordance with embodimentsof the subject matter disclosed herein.

FIGS. 13A and 13B are schematic diagrams depicting operation of anotherexemplary anchoring deployment mechanism, in accordance with embodimentsof the subject matter disclosed herein.

While the disclosed subject matter is amenable to various modificationsand alternative forms, specific embodiments have been shown by way ofexample in the drawings and are described in detail below. Theintention, however, is not to limit the subject matter disclosed hereinto the particular embodiments described. On the contrary, the disclosureis intended to cover all modifications, equivalents, and alternativesfalling within the scope of the subject matter disclosed herein, and asdefined by the appended claims.

DETAILED DESCRIPTION

Embodiments disclosed herein include a circulatory support device havingan anchoring device configured to be employed with a heart. Theanchoring device may be configured to prevent inadvertent migration ofthe circulatory support device from an exemplary location duringoperation of the circulatory support device. For example, the anchoringdevice may be configured to reduce the likelihood of translation of thecirculatory support device into or out of the aorta. As another example,the anchoring device may be configured to center the circulatory supportdevice within the aortic valve to prevent the circulatory support devicefrom being biased toward the perimeter of the aortic valve resulting inaortic regurgitation. Centering of the circulatory support device mayalso have the added benefit of mitigating abrasion to the aortic valveleaflets by the circulatory support device. Furthermore, by reducing thelikelihood of device contact with the annulus of the aortic valve, theprobability of disrupting calcification from the aortic valve resultingin embolization is reduced, which reduces the risk of stroke or otherorgan damage. A centered device is also less likely to engage the mitralvalve elements such as the papillary heads or chordae tendineae. Anotheradvantage of a centered device is the likelihood of contact with theleft ventricle walls is reduced, especially the septal wall which mightresult in ectopic beats.

FIG. 1 depicts a conceptual diagram of a circulatory support device 102having an exemplary anchoring device 104 anchored within a heart 106, inaccordance with embodiments of the subject matter disclosed herein.According to embodiments, the circulatory support device 102 may be aventricular assist device, such as a pump, that is configured to pumpblood from a left ventricle 108 of a subject into the subject's aorta110. More specifically, a distal portion 112 of the circulatory supportdevice 102 is arranged in the left ventricle 108. The circulatorysupport device 102 extends through the aortic valve 114 so that aproximal portion 116 extends into the aorta 110. During operation, thecirculatory support device 102 draws blood from the left ventricle 108,through a cannula 118 of the circulatory support device 102 and isreleased into the aorta 110. Additionally, or alternatively, thecirculatory support device 102 may be used to facilitate pumping bloodfrom some other aspect of the subject's heart and/or vasculature into anadjacent portion of the heart and/or vasculature.

The longitudinal, central axis 120 bisects the aortic valve 114. Inexemplary embodiments, the cannula 118 of the circulatory support device102 is centered and extends along the longitudinal, central axis 120 sothat the circulatory support device 102 is centered in the aortic valve114. In the event the circulatory support device 102 is not centeredwithin the aortic valve 114, the circulatory support device 102 mayprevent the aortic valve 114 from closing, resulting in aorticregurgitation (i.e., where blood flows backward from the aorta 110 toleft ventricle 108). Such positioning can also damage the leaflets ofthe aortic valve 114. Furthermore, in exemplary embodiments, thecirculatory support device 102 should not translate in a distaldirection 122 or a proximal direction 124. Otherwise, the circulatorysupport device 102 may project farther into the left ventricle 108 orthe aorta 110 than intended, reducing and/or eliminating the usefulnessof the circulatory support device 102. Conventional embodiments do notadequately address these problems. The embodiments disclosed herein,however, provide a solution to these problems by including an anchoringdevice 104 releasably coupled to the circulatory support device 102 suchthat the anchoring device 104 anchors to the heart 102 to preventtranslational movement of the circulatory support device 102 and/orradial movement of the circulatory support device 102, as described inmore detail below.

The illustrative system shown in FIG. 1 is not intended to suggest anylimitation as to the scope of use or functionality of embodiments of thepresent disclosure. The system also should not be interpreted as havingany dependency or requirement related to any single component orcombination of components illustrated therein. Additionally, variouscomponents depicted in FIG. 1 may be, in embodiments, integrated withvarious ones of the other components depicted therein (and/or componentsnot illustrated), all of which are considered to be within the ambit ofthe present disclosure.

FIG. 2 depicts a conceptual diagram of an exemplary implantationlocation of a circulatory support device 102 having an exemplaryanchoring device 104, in accordance with embodiments of the subjectmatter disclosed herein. In exemplary embodiments, the circulatorysupport device 102 should be positioned so that the outflow windows 126of the circulatory support device 102 are approximately 10 millimeters(mm) proximal the right coronary artery (RCA) 128 and left main artery(LMA) 130 to facilitate efficient blood flow out of the circulatorysupport device 102 into the aorta 110. In exemplary embodiments, theoutflow windows 126 of the circulatory support device 102 should alsonot be positioned over the brachiocephalic artery 132. Instead, theoutflow windows 126 should be positioned 10 mm distal to thebrachiocephalic artery 132.

In embodiments, the anchoring device 104 facilitates maintaining thecirculatory support device 102 in the exemplary position describedabove. For example, the circulatory support device 102 may be positionedin the exemplary position described above. After or during thepositioning of the circulatory support device 102, the anchoring device104 may be delivered, in a constrained configuration, over or within adelivery catheter (not shown) so the distal portion 104A is arrangedover a proximal portion 102A of the circulatory support device 102. Inembodiments, elements of the distal portion 104A may define an annulus(see, e.g., FIG. 4B) through which the circulatory support device 102can be received. To maintain the anchoring device 104 in a constrainedstate, a constraining member (not shown) may be arranged around theanchoring device 104. The constraining member be a sleeve, a sheath, acatheter, and/or the like. Exemplary constraining members are describedin more detail below in relation to FIGS. 7A-13B.

In embodiments, the distal portion 104A of the anchoring device 104 maybe releasably coupled to the proximal portion 102A of the circulatorysupport device 102. To do so, the proximal portion 102A may include loopelements 134 through which elongate members 136 of the anchoring device104 are inserted. As stated above, the elongate members 136 may definean annulus (see, e.g., FIG. 4B) through which the anchoring device 104can be arranged. In embodiments, the loop elements 134 and the elongatemembers 136 may form an interference fit to prevent inadvertentdetachment of the elongate members 136 by the loop elements 134.

Either before or after coupling the distal portion 104A to the proximalportion 102A, the constraining member may be removed from the anchoringdevice 104 so the anchoring device 104 can circumferentially expand toan unconstrained state (as shown). In the unconstrained state, theanchoring device 104 may include a proximal portion 104B that expands tohave a cross section diameter that is larger than the diameter definedby the annulus of the distal portion 104A. As such, edges 104C of theproximal portion 104B expand so the edges 104C contact and abut thewalls of the aorta 114. Due to the contact between the anchoring device104 and the walls of the aorta 114, the anchoring device 104 anchors thecirculatory support device 102 to the heart 106. In embodiments, theanchoring device 104 may allow for blood to freely pass along theoutside of the circulatory support device 102. In embodiments, theanchoring device 104 may expand to have a conical shape as shown. Inembodiments, the anchoring device 104 may be formed from nitinol.Additional exemplary embodiments of anchoring devices are describedbelow in relation to FIGS. 3-5B.

The illustration shown in FIG. 2 is not intended to suggest anylimitation as to the scope of use or functionality of embodiments of thepresent disclosure. The illustration also should not be interpreted ashaving any dependency or requirement related to any single component orcombination of components illustrated therein. Additionally, variouscomponents depicted in FIG. 2 may be, in embodiments, integrated withvarious ones of the other components depicted therein (and/or componentsnot illustrated), all of which are considered to be within the ambit ofthe present disclosure.

FIG. 3 depicts a side view of an illustrative circulatory support device202 having an anchoring device 204, in accordance with embodiments ofthe subject matter disclosed herein. According to embodiments, thecirculatory support device 202 may be, or be similar to, the circulatorysupport device 102 depicted in FIG. 1 . Additionally, or alternatively,the anchoring device 204 may be or be similar to, the anchoring device104 depicted in FIG. 1 .

According to embodiments, the circulatory support device 202 may be aventricular assist device configured to pump blood from a left ventricle(e.g., the left ventricle 108) of a subject into the subject's aorta(e.g., the aorta 106). In embodiments, the circulatory support device202 may be used to facilitate pumping blood from some other aspect ofthe subject's heart and/or vasculature into an adjacent portion of theheart and/or vasculature. As shown in FIG. 3 , the circulatory supportdevice 202 includes a blood pump assembly 206 having a distal end 208 atleast partially surrounded by a flexible inlet tube 210. A number ofblood flow outlet apertures 212 are disposed in a pump assembly 206proximal to the flexible inlet tube 208. Similar to the embodimentdepicted in FIG. 2 , a distal portion 204A of the anchoring device 204may be coupled to the pump assembly 206 either before, during, or afterimplantation of the circulatory support device 202.

In embodiments, the anchoring device 204 also includes a proximalportion 204B that extends proximally and radially outward from alongitudinal, central axis 214. In the illustrated embodiment, theproximal portion 204B includes a plurality of proximal portions 216A,216B, 216C. Each proximal portion 216A-216C forms a loop. For example,each proximal portion 216A-216C may include a first end 218 and a secondend 220, each of which are coupled to the pump assembly 206. Inembodiments, the first and second ends 218, 220 may form an annulusthrough which the pump assembly 306 is inserted. Between the first andsecond ends 218, 220, the proximal portions 216A-216C extend in aproximal direction 222. After extending in a proximal direction 222 fora distance, each proximal portion 216A-216C reaches a distal end 224,then loops back and extends in a distal direction 226 back to the firstand second ends 220, 222. In embodiments, the distal ends 224 mayinclude barbs for securing the anchoring device 204 to the aorta. Inembodiments, the proximal portions 216A-216C may form a basketstructure. In embodiments, the proximal portions 216A-216C may overlapor they may not overlap.

In embodiments, the proximal portions 216A-216C may be delivered in aconstrained state by, for example, a constraining member (not shown).The constraining member be a sleeve, a sheath, a catheter, and/or thelike. Exemplary constraining members are described in more detail belowin relation to FIGS. 7A-13B. The constraining member may be removed fromthe anchoring device 204 so the anchoring device 204 cancircumferentially expand to an unconstrained state (as shown) in orderto fix the circulatory support device 202 in an exemplary position, asdescribed above. In embodiments, the proximal portions 216A-216C may beequidistant from the central axis 214.

The illustration shown in FIG. 3 is not intended to suggest anylimitation as to the scope of use or functionality of embodiments of thepresent disclosure. The illustration also should not be interpreted ashaving any dependency or requirement related to any single component orcombination of components illustrated therein. Additionally, variouscomponents depicted in FIG. 3 may be, in embodiments, integrated withvarious ones of the other components depicted therein (and/or componentsnot illustrated), all of which are considered to be within the ambit ofthe present disclosure.

FIG. 4A depicts a side view of a portion of a circulatory support device302 having another exemplary anchoring device 304, in accordance withembodiments of the subject matter disclosed herein. FIG. 4B depicts anend view of the circulatory support device of FIG. 4A, in accordancewith embodiments of the subject matter disclosed herein. According toembodiments, the circulatory support device 302 may be, or be similarto, the circulatory support device 102 depicted in FIG. 1 and/or thecirculatory support device 202 depicted in FIG. 3 . Additionally, oralternatively, the anchoring device 304 may be or be similar to, theanchoring device 104 depicted in FIG. 1 and/or the anchoring device 204depicted in FIG. 3 .

According to embodiments, the circulatory support device 302 may be aventricular assist device configured to pump blood from a left ventricle(e.g., the left ventricle 108) of a subject into the subject's aorta(e.g., the aorta 106). In embodiments, the circulatory support device302 may be used to facilitate pumping blood from some other aspect ofthe subject's heart and/or vasculature into an adjacent portion of theheart and/or vasculature. As shown in FIG. 4A, the circulatory supportdevice 302 includes a blood pump assembly 306 having a distal end 308 atleast partially surrounded by a flexible inlet tube 310. Similar to theembodiment depicted in FIG. 3 , a distal portion 304A of the anchoringdevice 304 may be coupled to the pump assembly 306 either before,during, or after implantation of the circulatory support device 302. Inembodiments, the anchoring device 304 also includes a proximal portion304B that extends proximally and radially outward from a longitudinal,central axis 314. In the illustrated embodiment, the proximal portion304B includes a plurality of proximal portions 316A, 316B, 316C. Eachproximal portion 316A-316C forms a loop. For example, each proximalportion 316A-316C may include a first end 318 and a second end 320, eachof which are coupled to the pump assembly 306. In embodiments, the firstand second ends 318, 320 may form an annulus through which the pumpassembly 306 is inserted. Between the first and second ends 318, 320,the proximal portions 316A-316C extend in a proximal direction 322.After extending in a proximal direction 322 for a first distance, eachproximal portion 316A-316C reaches a first intermediate point 324, thenextends in a distal direction 326 for a second distance that is shorterthan the first distance. After extending in a proximal direction 322 forthe second distance, each proximal portion 316A-316C reaches a secondintermediate point 328, then extends in a proximal direction for a thirddistance. The third distance may be approximately equal to the seconddistance. After extending in a proximal direction 322 for the thirddistance, each proximal portion 316A-316C reaches a distal end 330. Theneach proximal portion 316A-316C extends in a distal direction 326 forthe third distance then back in a proximal direction 322 for the seconddistance and then back in a distal direction 326 for the first distanceto the second end 322. In embodiments, the distal ends 324 may includebarbs for securing the anchoring device 304 to the aorta. Inembodiments, the proximal portions 316A-316C may form a basketstructure. In embodiments, the proximal portions 316A-316C may overlapor they may not overlap.

In embodiments, the proximal portions 316A-316C may be delivered in aconstrained state by, for example, a constraining member (not shown).The constraining member be a sleeve, a sheath, a catheter, and/or thelike. Exemplary constraining members are described in more detail belowin relation to FIGS. 7A-13B. The constraining member may be removed fromthe anchoring device 304 so the anchoring device 304 cancircumferentially expand to an unconstrained state (as shown) in orderto fix the circulatory support device 302 in an exemplary position, asdescribed above. In embodiments, the proximal portions 316A-316B may beequidistant from the central axis 314.

The illustration shown in FIGS. 4A-4B is not intended to suggest anylimitation as to the scope of use or functionality of embodiments of thepresent disclosure. The illustration also should not be interpreted ashaving any dependency or requirement related to any single component orcombination of components illustrated therein. Additionally, variouscomponents depicted in 4A-4B may be, in embodiments, integrated withvarious ones of the other components depicted therein (and/or componentsnot illustrated), all of which are considered to be within the ambit ofthe present disclosure.

FIGS. 5A and 5B depict a conceptual end view of another exemplaryanchoring device 400, in accordance with embodiments of the subjectmatter disclosed herein. More specifically, FIG. 5A depicts a conceptualend view of another exemplary anchoring device 400 in a constrainedconfiguration and FIG. 5B depicts a conceptual end view of the exemplaryanchoring device 400 depicted in FIG. 5A in an unconstrainedconfiguration. According to embodiments, the anchoring device 400 may beor be similar to, the anchoring device 104 depicted in FIG. 1 , theanchoring device 204 depicted in FIG. 3 , and/or the anchoring device304 depicted in FIG. 4 .

In the illustrated embodiment, the anchoring device 400 has a proximalportion 402 including plurality of elongate members 404 surrounded by amembrane 406. In embodiments, the elongate members 404 and membrane 406are centered about a central axis 408. When in a constrainedconfiguration, the proximal portions 404 and the membrane 406 areconstrained by a constraining member 410. In embodiments, theconstraining member 408 may be a sleeve, a sheath, a catheter, and/orthe like. In embodiments, the membrane 406 includes overlapping portions412 that overlap when the anchoring device 400 is in a constrainedconfiguration, as illustrated in FIG. 5A. However, when the constrainingmember 410 is removed from the proximal portion 402, the elongatemembers 402 and surrounding membrane 406 circumferentially expand aboutthe central axis to an unconstrained configuration, as illustrated inFIG. 5B. In the unconstrained configuration, the membrane 406 may nolonger include overlapping portions 412. In embodiments, the outer edgesof the membrane 406 may be equidistant from the central axis 314.

FIGS. 5A and 5B depict a conceptual cross-sectional view of acirculatory support device having another exemplary anchoring device, inaccordance with embodiments of the subject matter disclosed herein.Another embodiment consists of a sheathed frame that is folded onitself. When unsheathed, it opposes the aortic walls. This designfunctions like a folded balloon on a balloon catheter. This could be aselectively deployable anchoring device as well as a non-selectivelydeployable device dependent on the introducer sheath that is used. Thesheathed frame would need to be resilient enough to survive folding uponitself over the cannula of the device and fold easily back onto thesurface of the cannula when being recaptured for removal.

FIG. 6 depicts a conceptual cross-sectional delivery catheter 500, inaccordance with embodiments of the subject matter disclosed herein. Asset forth above, the anchoring devices 104, 204, 304, 400 may bearranged over a circulatory support device via a delivery catheter. Inembodiments, the delivery catheter 500 could have a tricuspidcross-sectional shape, as illustrated in FIG. 6 . In embodiments, thetricuspid shape could mimic the shape of the aortic valve (e.g., theaortic valve 114). This shape could allow for improved leafletcoaptation against the aortic valve itself. Additionally, oralternatively, this shape may facilitate centering of the anchoringdevice 104, 204, 304, 400 to reduce the likelihood of aorticregurgitation.

FIGS. 7A and 7B are schematic diagrams depicting operation of anexemplary anchoring deployment mechanism 600, in accordance withembodiments of the subject matter disclosed herein. In the illustratedembodiment, the anchoring device 502 is arranged within a catheter 504.In embodiments, the anchoring device 502 may be, or be similar to, theanchoring device 104 depicted in FIG. 1 , the anchoring device 204depicted in FIG. 3 , the anchoring device 304 depicted in FIG. 4 ,and/or the anchoring device 400 depicted in FIG. 5 .

In embodiments, the catheter 504 includes openings 506 through which theanchoring device 502 protrudes. In embodiments, a distal end 502A of theanchoring device 502 is coupled to a distal end 508 of the catheter 504.Additionally, or alternatively, an actuation member 510 may be attachedto a proximal end 502B of the anchoring device 502. In the illustratedembodiment, the actuation member 510 is a push-pull rod. In aconstrained configuration, the actuation member 510 is arranged along aproximal position, as illustrated in FIG. 7B. To actuate the anchoringdevice 502, the actuation member 510 is biased in a distal directiontowards the distal end 508 of the catheter 504 to a distal position, asillustrated in FIG. 7A. Once in the distal position, the anchoringdevice 502 projects out of the openings 506 and circumferentiallyexpands to an expanded configuration, as illustrated in FIG. 7A.

FIGS. 8A and 8B are schematic diagrams depicting operation of anexemplary anchoring deployment mechanism 700, in accordance withembodiments of the subject matter disclosed herein. In the illustratedembodiment, the anchoring device 602 is arranged within a catheter 604.In embodiments, the anchoring device 602 may be, or be similar to, theanchoring device 104 depicted in FIG. 1 , the anchoring device 204depicted in FIG. 3 , the anchoring device 304 depicted in FIG. 4 ,and/or the anchoring device 400 depicted in FIG. 5 .

In embodiments, the catheter 604 includes openings 606 through which theanchoring device 602 protrudes. In embodiments, a distal end 602A of theanchoring device 602 is coupled to a distal end 608 of the catheter 604.Additionally, or alternatively, an actuation member 610 may be attachedto a proximal end 602B of the anchoring device 602. In the illustratedembodiment, the actuation member 610 are push-pull wires 610. In aconstrained configuration, the actuation member 610 is arranged along aproximal position, as illustrated in FIG. 8B. To actuate the anchoringdevice 602, the actuation member 610 is biased in a distal directiontowards the distal end 608 of the catheter 604 to a distal position, asillustrated in FIG. 8A. Once in the distal position, the anchoringdevice 602 projects out of the openings 606, as illustrated in FIG. 8A.

FIGS. 9A and 9B are schematic diagrams depicting operation of anotherexemplary anchoring deployment mechanism 800, in accordance withembodiments of the subject matter disclosed herein. In the illustratedembodiment, the anchoring device 702 is arranged within a catheter 704.In embodiments, the anchoring device 702 may be, or be similar to, theanchoring device 104 depicted in FIG. 1 , the anchoring device 204depicted in FIG. 3 , the anchoring device 304 depicted in FIG. 4 ,and/or the anchoring device 400 depicted in FIG. 5 .

In embodiments, the catheter 704 includes openings 706 through which theanchoring device 702 protrudes. In embodiments, an actuation member 708may be attached to the anchoring device 702. In the illustratedembodiment, the actuation member 708 is a push-pull rod. In aconstrained configuration, the actuation member 708 is arranged in adistal position, as illustrated in FIG. 9B. To actuate the anchoringdevice 702, the actuation member 708 is biased in a proximal directionto a distal position, as illustrated in FIG. 9A. Once in the proximalposition, the anchoring device 702 projects out of the openings 706, asillustrated in FIG. 9A.

FIGS. 10A and 10B are schematic diagrams depicting operation of anotherexemplary anchoring deployment mechanism 900, in accordance withembodiments of the subject matter disclosed herein. In the illustratedembodiment, the anchoring device 802 is arranged within a catheter 804.In embodiments, the anchoring device 802 may be, or be similar to, theanchoring device 104 depicted in FIG. 1 , the anchoring device 204depicted in FIG. 3 , the anchoring device 304 depicted in FIG. 4 ,and/or the anchoring device 400 depicted in FIG. 5 .

In embodiments, the catheter 804 includes openings 806 through which theanchoring device 802 protrudes. In embodiments, the openings 806 mayinclude cut-outs so the anchoring device 802 is entirely containedwithin the catheter 804. In embodiments, an actuation member 808 may beattached to the anchoring device 802. In the illustrated embodiment, theactuation member 808 is a push-pull rod. In a constrained configuration,the actuation member 808 is arranged in a distal position, asillustrated in FIG. 10B. To actuate the anchoring device 802, theactuation member 808 is biased in a proximal direction to a distalposition, as illustrated in FIG. 10A. Once in the proximal position, theanchoring device 802 projects out of the openings 806, as illustrated inFIG. 10A.

FIGS. 11A and 11B are schematic diagrams depicting operation of anotherexemplary anchoring deployment mechanism 1000, in accordance withembodiments of the subject matter disclosed herein. In the illustratedembodiment, the anchoring device 902 is arranged on an exterior of acatheter 904. In embodiments, the anchoring device 902 may be, or besimilar to, the anchoring device 104 depicted in FIG. 1 , the anchoringdevice 204 depicted in FIG. 3 , the anchoring device 304 depicted inFIG. 4 , and/or the anchoring device 400 depicted in FIG. 5 .

In embodiments, the catheter 904 includes a constraining member 906arranged around the catheter 904. In embodiments, an actuation member908 may be attached to the constraining member 906. In the illustratedembodiment, the actuation member 908 is a pulley system. In aconstrained configuration, the constraining member 906 is arranged in aproximal position, as illustrated in FIG. 10B. In the proximal position,the constraining member 906 is arranged around the anchoring device 902and holds the anchoring device 902 against the exterior of the catheter904. To actuate the anchoring device 902, the actuation member 908 isactuated to move the constraining member 906 in a distal direction to adistal position, as illustrated in FIG. 11A. Once in the distalposition, the anchoring device 902 is no longer constrained against theexterior of the catheter 904 so the anchoring device 902 projectsoutward from the sides of the catheter 904.

FIGS. 12A-12C are schematic diagrams depicting operation of anotherexemplary anchoring deployment mechanism 1100, in accordance withembodiments of the subject matter disclosed herein. In the illustratedembodiment, the anchoring device 1002 is arranged within a constrainingmember 1004. In embodiments, the anchoring device 1002 may be, or besimilar to, the anchoring device 104 depicted in FIG. 1 , the anchoringdevice 204 depicted in FIG. 3 , the anchoring device 304 depicted inFIG. 4 , and/or the anchoring device 400 depicted in FIG. 5 .

In embodiments, the constraining member 1004 may be arranged on anexterior of a catheter 1006. In a constrained configuration, theconstraining member 1004 is arranged in a distal position, asillustrated in FIG. 12A. In the distal position, the constraining member1006 constrains the anchoring device 1002 longitudinally, as illustratedin FIG. 12A. To actuate the anchoring device 1002, the constrainingmember 1004 is moved in a proximal direction. As the constraining member1004 is moved in a proximal direction the anchoring device 1002 is nolonger constrained and projects out of a distal end 1008 of theconstraining member 1004, as illustrated in FIGS. 12B and 12C. Afterprojecting out of the distal end 1008 of the constraining member 1004,the anchoring device 1002 assumes its predefined shape which is a helixthat surrounds the catheter 1006, as illustrated in FIG. 12C.

FIGS. 13A and 13B are schematic diagrams depicting operation of anotherexemplary anchoring deployment mechanism 1200, in accordance withembodiments of the subject matter disclosed herein. In the illustratedembodiment, the anchoring device 1102 is arranged on an interior acatheter 1104. In embodiments, the anchoring device 1102 may be, or besimilar to, the anchoring device 104 depicted in FIG. 1 , the anchoringdevice 204 depicted in FIG. 3 , the anchoring device 304 depicted inFIG. 4 , and/or the anchoring device 400 depicted in FIG. 5 .

In embodiments, the catheter 1104 includes a proximal portion 1104A anda distal portion 1104B. In embodiments, an actuation member 1106 may beattached to the proximal portion 1104A. In the illustrated embodiment,the actuation member 1106 is an electrical wire. In a constrainedconfiguration, the proximal portion 1104A abuts the distal portion1104B, as illustrated in FIG. 13A. In the constrained configuration, thecatheter 1104 constrains the anchoring device 1102 within an interior ofthe catheter 1104. To actuate the anchoring device 1102, the actuationmember 1106 is actuated to move the proximal portion 1104A in a proximaldirection to a proximal position, as illustrated in FIG. 13B. Once theproximal portion 1104A is in the proximal position, the anchoring device1102 is no longer constrained within an interior of the catheter 1104 sothe anchoring device 1102 projects outward.

Various modifications and additions can be made to the exemplaryembodiments discussed without departing from the scope of the presentdisclosure. For example, while the embodiments described above refer toparticular features, the scope of this disclosure also includesembodiments having different combinations of features and embodimentsthat do not include all of the described features. Accordingly, thescope of the present disclosure is intended to embrace all suchalternatives, modifications, and variations as fall within the scope ofthe claims, together with all equivalents thereof.

What is claimed is:
 1. A method for delivering an anchoring apparatusfor positioning a cardiac pump, the method comprising: arranging theanchoring apparatus over or within a delivery catheter, the anchoringapparatus comprising: an expandable anchoring device extending along alongitudinal axis, wherein the expandable anchoring device is arrangedabout a central axis, wherein a distal portion of the expandableanchoring device defines an annulus through which the cardiac pump canbe arranged and to which the cardiac pump can be releasable coupled, andwherein a proximal portion of the expandable anchoring device isconfigured to circumferentially expand to an unconstrained configurationthat has a cross-sectional diameter greater than a diameter of theannulus; and a constraining member arranged over the expandableanchoring device to constrain the expandable anchoring device in aconstrained configuration for delivery of the anchoring apparatus;arranging a cardiac pump within a subject's heart; and subsequentlyadvancing the anchoring apparatus within the subject's aorta and overthe cardiac pump arranged within the subject's heart; releasablycoupling the anchoring apparatus to the cardiac pump; and actuating theanchoring apparatus from its constrained configuration.
 2. The method ofclaim 1, wherein the anchoring apparatus further comprises an actuationmember, wherein the constraining member is a sheath arranged around theproximal portion that comprises at least one aperture, and whereinactuating the anchoring apparatus comprises actuating the actuationmember so the anchoring apparatus projects through the at least oneaperture of the sheath.
 3. The method of claim 1, wherein theconstraining member is a sheath arranged around the proximal portion,and wherein actuating the anchoring apparatus comprises translating thesheath so that it is no longer arranged around the proximal portion. 4.The method of claim 1, wherein the distal portion includes an elongatemember that is secured to a coupling loop of the cardiac pump via aninterference fit, and wherein releasably coupling the anchoringapparatus to the cardiac pump comprises inserting the elongate memberthrough the coupling loop.
 5. The method of claim 1, further comprisingremoving the anchoring apparatus by arranging the constraining memberover the expandable anchoring device and withdrawing the anchoringapparatus.
 6. The method of claim 1, wherein the proximal portion has aconical shape.
 7. The method of claim 1, wherein the distal portioncomprises portions that are overlapping when in the constrainedconfiguration and are non-overlapping when in the unconstrainedconfiguration.
 8. The method of claim 7, wherein the plurality ofproximal portions comprise a plurality of separate, elongate members. 9.The method of claim 1, wherein the proximal portion comprises aplurality of proximal portions that, are configured to expandequidistant from the central axis when in the unconstrainedconfiguration.
 10. The method of claim 1, further comprising engagingthe subject's aorta with the anchoring apparatus in its unconstrainedconfiguration.
 11. The method of claim 10, wherein engaging thesubject's aorta with the anchoring apparatus in its unconstrainedconfiguration centers the cardiac pump in the subject's aortic valve.